Viral Safety by Design for Cell and Gene Therapy Products


24th May 2019 | 10.00 am EDT | Mark Plavsic, Chief Technology Officer at Lysogene and Archie Lovatt, Life Sciences Biosafety Scientific Director at SGS |BOOK FREE SEAT

Together with product efficacy, product safety is an essential characteristic of any medicinal product including cell and gene therapy (C&GT) biologics. Adventitious agents (viruses, bacteria, mycoplasma, prions, etc) pose constant risk to these biologics, and, as such they may impact directly product and patient safety. It is therefore of supreme importance to intentionally (by design) employ effective measures across the whole C&GT product manufacturing process to mitigate risk of adventitious agents. This presentation will review various interconnected steps throughout the manufacturing process, from the raw materials to the fill and finish, that would, in concert, help mitigate the risk while providing a high degree of product safety by design.

Presented by Mark Plavsic, Chief Technology Officer at Lysogene

Mark is Chief Technology Officer at Lysogene, a late stage clinical development gene therapy company with headquarters in Paris, France. Prior to joining Lysogene, Mark was SVP of Process Development & Manufacturing at Torque Therapeutics, Inc., an immuno-oncology company located in Cambridge, MA. Prior to joining Torque, Mark served as Head of Product Biosafety at Genzyme/Sanofi responsible for process improvements and bio-safety of biological products and associated manufacturing processes. Previously, Mark was in charge of gene therapy development at Genzyme, overseeing the upstream, downstream, formulation and analytical developments of viral vectors used in gene therapy applications. Prior to Genzyme, Mark held senior positions with AstraZeneca, Q-One Biotech, and Life Technologies, Inc. Mark’s technical experience spans across a wide spectrum of drug development and manufacturing activities, including raw materials, R&D, QC testing, GLP non-clinical studies, process development, GMP manufacturing, GMP contract testing, and GMP contract manufacturing.

Mark’s education includes doctor of veterinary medicine (DVM) degree, MSc, and PhD degree in virology and immunology.

Sponsored by SGS Life Sciences

SGS Life Sciences is a leading contract service organization providing analytical development, biologics characterization, biosafety and quality control testing. Operating a wholly-owned network of 18 laboratories in 11 countries, SGS delivers complete lifecycle solutions for pharmaceutical, biologics, and medical device manufacturers.  Our services include: analytical chemistry, microbiology, stability studies, bioanalysis, extractables/leachables, virology and protein analysis.

SGS is experienced in testing extractables and leachables from primary and secondary packaging for pharmaceuticals, process equipment including single use systems, and components parts from medical devices. SGS designs and performs extractable and leachable studies that will satisfy regulatory authorities such as the FDA and EMA as well as adhere to ASTM, ISPE, PQRI, BPOG, BPSA, and PDA recommendations.

 

Archie Lovatt Life Sciences Biosafety Scientific Director at SGS

Archie Lovatt is a biopharmaceutical, vaccine, gene and cell therapy biosafety testing expert. He graduated from University of Glasgow with a BSc (Hons) in Microbiology in 1990. He continued his studies at the Medical Sciences Institute, University of Leicester researching the genetic analysis of microbial virulence factors, and graduated with a PhD in molecular microbiology. In 1994, Dr. Lovatt was awarded a post-doctoral fellowship at the Cancer Research UK Beatson Institute to genetically dissect transcriptional factors and investigate their role in central nervous system cellular differentiation. Between 1996 and 2007, he was Scientific Director of Q-One Biotech-BioReliance-Invitrogen (under Life Technologies) based in Glasgow UK. He pioneered the development and implementation of quantitative PCR and PERT services for the testing of cell substrates and viral vectors/vaccines. During his 11 year tenure, Dr. Lovatt built & directed several assay development, validation and testing teams and implemented the Q-One Biotech and BioReliance R&D pipeline into routine operations at Glasgow. Until 2005, he focused on molecular biology and virology divisions, and also in the routine lot release testing operations under GLP/cGMP compliance. Thereafter he played role in technical direction, R&D, regulatory services, business development, and in strategic direction. In early 2007, Dr. Lovatt co-founded the world class high growth CRO Vitrology (acquired by SGS in 2012) and served on the board as Scientific Operations Director, a position he holds to the present day. In 2015 & 2016, he was in the top 100 most influential people in human medicine development and manufacture. He serves on USP scientific expert volunteer goups.

 

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